HIV Infections
Conditions
Brief summary
Prospective Clinical Trial of HIV+ Living Donor Kidney Donation for HIV+ Recipients
Detailed description
This is a prospective study to evaluate the safety of donor nephrectomy in HIV+ individuals who donate kidneys to HIV+ candidates in need of transplant . The study will assess potential complications of HIV + living donors - including adverse events related to nephrectomy, development of chronic kidney disease, hypertension, and HIV-related complications.
Interventions
None listed
Sponsors
Johns Hopkins University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to understand and provide consent * Age 21 years or older * Meets standard clinical criteria for living donation per Johns Hopkins University (JHU) Comprehensive Transplant Center Policy * Documented HIV infection (by any licensed Enzyme-linked Immunosorbent Assay (ELISA) and confirmation by Western Blot, positive HIV Ab Immunofluorescent Assay (IFA), or documented history of detectable HIV-1 RNA) * CD4+ T-cell count ≥ 500/µL for 6 months prior to donation * HIV-1 RNA below 50 copies RNA/mL (viral blips between 50-400 copies will be allowed as long as there are not consecutive measurements \>200 copies/mL)
Exclusion criteria
* Two high risk alleles of APOL1 (G1 or G2 variants) * Hypertension * Diabetes * Chronic active hepatitis C (detectable HCV RNA in plasma) * Evidence of invasive opportunistic complications from HIV infection * Mentally incompetent and/or inability to provide informed consent * Other medical conditions, as determined by the provider, that would preclude donation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | at 1 year | incidence of adverse events related to nephrectomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| chronic kidney disease | through to study completion, up to 4 years | time to significant proteinuria or glomerular filtration rate below 60 ml/min |
| hypertension | through to study completion, up to 4 years | time to hypertension defined as systolic blood pressure \> 140 mm Hg confirmed |
| change in antiretroviral therapy | through to study completion, up to 4 years | proportion of participants requiring change in antiretroviral therapy |
| HIV virologic control | through to study completion, up to 4 years | proportion of participants with HIV virologic failure or breakthrough |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristine Durand, MD
Johns Hopkins University
Outcome results
None listed